FDA 510(k)

M.U.S.T. 椎板螺釘系統 - 延伸版

K 號：K253940 · 2026-04-28

決定日期2026-04-28

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

M.U.S.T. Pedicle Screw System - Extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K253940. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M.U.S.T. Pedicle Screw System - Extension?

M.U.S.T. Pedicle Screw System - Extension is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Medacta International S.A.. The 510(k) number is K253940.

When did M.U.S.T. Pedicle Screw System - Extension receive FDA 510(k) clearance?

M.U.S.T. Pedicle Screw System - Extension received FDA 510(k) clearance on 2026-04-28, under 510(k) number K253940.

Who is the listed applicant for M.U.S.T. Pedicle Screw System - Extension?

FDA 510(k) 記錄將 Medacta International S.A. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for M.U.S.T. Pedicle Screw System - Extension?

The FDA product code for M.U.S.T. Pedicle Screw System - Extension is NKB.

其他以 Medacta International S.A. 為申請人之記錄

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相關器械（代碼：NKB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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